Ventricular FlutterPPM in TAVRNCT02994667
Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR)
An observational study of Ventricular Flutter and Atrioventricular Block, run by Baylor Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to assess the incidence (at 90-days) of ventricular pacing in patients undergoing permanent pacemaker placement after TAVR. As well as incidence (at 90-days) of atrioventricular block (AVB), intraventricular conduction delay (IVCD), bundle branch block (BBB), and rate histogram in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Flutter, Atrioventricular Block, Intraventricular Conduction Delay
- What is being tested?
- Permanent Pacemaker Placement
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 20 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study cohort will comprise all consecutive patients who undergo permanent pacemaker placement for new conduction disturbances after TAVR at THHBP between 1/1/2015 and 12/31/2016 and will consist of up to 50 patients.
Who may be able to join
- Patients > 18 years of age
- Patients undergoing Transcatheter Aortic Valve Replacement
- Indication for PPM including:
- Persistent 3rd degree AVB
- Transient 3rd degree AVB
- New Left BBB
Show all 10Show fewer
- New bifascicular block
- New first degree AV block
- Any conduction disturbance determined by the investigator to be related to the TAVR procedure 4. Patients receiving post-TAVR PPM with one of the following devices
- Medtronic: i. ADAPTA DR -ADDR01 ii. ADAPTA L DR-ADDRL1 iii. ADVISA MRI-A2DR01 b. St. Jude Medical: i. Zypher 5820 ii. Zypher 5826 iii. Accent pm2110 iv. Accent pm2210 v. Assurity pm2240 vi. Endurity Pm2160
Who cannot join
- Pregnancy-Women of childbearing potential should have negative urine 'pregnancy test prior to enrollment
- Patients with implanted pacemaker
- Patients with implantable cardiac defibrillator
- Indication for post TAVR PPM not related to the procedure including sinus node dysfunction/sick sinus syndrome.
- Medically unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The Heart Hospital Baylor of Plano
Plano, Texas, 75093
About this study
The purpose of this study is to assess the incidence (at 90-days) of ventricular pacing in patients undergoing permanent pacemaker placement after TAVR.
As well as incidence (at 90-days) of atrioventricular block (AVB), intraventricular conduction delay (IVCD), bundle branch block (BBB), and rate histogram in patients undergoing permanent pacemaker placement after TAVR.
Read the detailed description
Development of atrioventricular (AV) conduction system abnormalities requiring placement of a permanent pacemaker (PPM) is a known complication of transcatheter aortic valve replacement (TAVR). Male gender, pre-existing AV conduction system abnormalities, transient AV block intra-procedurally, and use of a self-expanding valve have all been associated with increased risk of AV block and need for permanent pacemaker placement. Persistent AV conduction abnormalities have been documented in approximately 15% of patients who receive an Edwards Sapien valve, with 4% requiring permanent pacemaker placement. 22-28% of patients who receive a CoreValve require permanent pacemaker placement in some studies. In one study, 78% of patients who underwent His bundle electrogram assessment during CoreValve placement had transient or persistent AV conduction system abnormalities during the procedure.
Pacemakers placed at The Heart Hospital Baylor Plano are produced by two manufactures: Medtronic, Inc. and St. Jude Medical, Inc. Each of these manufacturers have pacemakers with algorithms designed to minimize right ventricular pacing. Medtronic's algorithm is referred to as "MVP" (Managed Ventricular Pacing), and St. Jude Medical's algorithm is referred to as "VIP" (Ventricular Intrinsic Preference). Each of these techniques purports to reduce unnecessary right ventricular (RV) pacing through a novel pacemaker algorithm. Both manufacturers' pacemaker programmers and remote monitoring systems allow for demonstration of the percentage of ventricular pacing performed by the device.
The Investigators propose to assess the 90 day- ventricular pacing, atrioventricular block (AVB), intraventricular conduction delay (IVCD), bundle branch block (BBB), and rate histogram incidence in those patients who undergo pacemaker implantation due to elevated risk (or occurrence of) high-grade AV block after TAVR.
- Conditions
- Ventricular Flutter, Atrioventricular Block, Intraventricular Conduction Delay, Bundle Branch Block, Pacemaker Implantation
- Being tested
- Permanent Pacemaker Placement
- Keywords
- Electrophysiology
- Medical subject headings
- Ventricular Flutter, Atrioventricular Block, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permanent Pacemaker PlacementDevice
| Study group | Role | What they receive |
|---|---|---|
| Pacemaker After TAVR | The study cohort will comprise all consecutive patients who undergo permanent pacemaker placement for new conduction disturbances after TAVR at THHBP between 1/1/2015 and 12/31/2016. Receives: Device: Permanent Pacemaker Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Ventricular Pacing
Incidence of Ventricular pacing post permanent pacemaker placement after TAVR as indicated by Pacemaker interrogation or remote monitoring system.
Measured: 7-90 days
Secondary outcomes (1)
Incidence of other conduction disturbances
Freedom from documented atrioventricular block (AVB), intraventricular conduction dely (IVCD), bundle branch block (BBB) as indicated by pacemaker interrogation or remote monitoring system.
Measured: 7-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startJan 2015
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular FlutterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Deville, MD, Principal investigator, The Heart Hospital Baylor of Plano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994667
- Sponsor's protocol ID
- 014-286
- Acronym
- PPM in TAVR
- Status last verified
- Jan 2020
- First submitted
- 18 Nov 2016
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data on the clinical and non-clinical risk factors will be summarized using means, standard deviations (SDs) and percentages. The Kaplan-Meier method will be used to construct a ventricular pacing free curve summarizing time-to ventricular pacing incidence in the study cohort -the competing risk of death will be accounted in the analysis.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR)
- ClinicalTrials.gov ID
- NCT02994667
- Acronym / sponsor ID
- PPM in TAVR / 014-286
- Conditions
- Ventricular Flutter, Atrioventricular Block, Intraventricular Conduction Delay, Bundle Branch Block, Pacemaker Implantation
- Keywords
- Electrophysiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the incidence (at 90-days) of ventricular pacing in patients undergoing permanent pacemaker placement after TAVR.
As well as incidence (at 90-days) of atrioventricular block (AVB), intraventricular conduction delay (IVCD), bundle branch block (BBB), and rate histogram in patients undergoing permanent pacemaker placement after TAVR.
Detailed description
Development of atrioventricular (AV) conduction system abnormalities requiring placement of a permanent pacemaker (PPM) is a known complication of transcatheter aortic valve replacement (TAVR). Male gender, pre-existing AV conduction system abnormalities, transient AV block intra-procedurally, and use of a self-expanding valve have all been associated with increased risk of AV block and need for permanent pacemaker placement. Persistent AV conduction abnormalities have been documented in approximately 15% of patients who receive an Edwards Sapien valve, with 4% requiring permanent pacemaker placement. 22-28% of patients who receive a CoreValve require permanent pacemaker placement in some studies. In one study, 78% of patients who underwent His bundle electrogram assessment during CoreValve placement had transient or persistent AV conduction system abnormalities during the procedure.
Pacemakers placed at The Heart Hospital Baylor Plano are produced by two manufactures: Medtronic, Inc. and St. Jude Medical, Inc. Each of these manufacturers have pacemakers with algorithms designed to minimize right ventricular pacing. Medtronic's algorithm is referred to as "MVP" (Managed Ventricular Pacing), and St. Jude Medical's algorithm is referred to as "VIP" (Ventricular Intrinsic Preference). Each of these techniques purports to reduce unnecessary right ventricular (RV) pacing through a novel pacemaker algorithm. Both manufacturers' pacemaker programmers and remote monitoring systems allow for demonstration of the percentage of ventricular pacing performed by the device.
The Investigators propose to assess the 90 day- ventricular pacing, atrioventricular block (AVB), intraventricular conduction delay (IVCD), bundle branch block (BBB), and rate histogram incidence in those patients who undergo pacemaker implantation due to elevated risk (or occurrence of) high-grade AV block after TAVR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacemaker After TAVR | – | Device: Permanent Pacemaker PlacementThe study cohort will comprise all consecutive patients who undergo permanent pacemaker placement for new conduction disturbances after TAVR at THHBP between 1/1/2015 and 12/31/2016. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort will comprise all consecutive patients who undergo permanent pacemaker placement for new conduction disturbances after TAVR at THHBP between 1/1/2015 and 12/31/2016 and will consist of up to 50 patients.
Key inclusion criteria (10 listed)
- Patients > 18 years of age
- Patients undergoing Transcatheter Aortic Valve Replacement
- Indication for PPM including:
Key exclusion criteria (5 listed)
- Pregnancy-Women of childbearing potential should have negative urine 'pregnancy test prior to enrollment
- Patients with implanted pacemaker
- Patients with implantable cardiac defibrillator
- Indication for post TAVR PPM not related to the procedure including sinus node dysfunction/sick sinus syndrome.
- Medically unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permanent Pacemaker Placement | Device | Pacemaker After TAVR |
Primary outcome
Incidence of Ventricular Pacing
Time frame: 7-90 days
Incidence of Ventricular pacing post permanent pacemaker placement after TAVR as indicated by Pacemaker interrogation or remote monitoring system.
1 secondary outcome
Incidence of other conduction disturbances
Time frame: 7-90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: Yes. Data on the clinical and non-clinical risk factors will be summarized using means, standard deviations (SDs) and percentages. The Kaplan-Meier method will be used to construct a ventricular pacing free curve summarizing time-to ventricular pacing incidence in the study cohort -the competing risk of death will be accounted in the analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Deville, MD principal investigator
The Heart Hospital Baylor of Plano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Flutter and Atrioventricular Block, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Ventricular Pacing (time frame: 7-90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.